Review of Third-Party Research Risk: Is there a role for IRBS?

Session II:
Do IRBs have a role in the review of
third-party research risks and if so, when?

Currently, there are no regulatory requirements to protect third parties and there is not a recognizable structure to support a collective effort to do so. This session will draw on real-world examples to explore the idea of expanding protections to cover third parties in some circumstances. Panelists will discuss whether and what support for this idea already exists in the field of research ethics and whether institutional review boards (IRBs) have a role to play in oversight of such protections should they be warranted.

Moderator: Leslie E. Wolf, JD, MPH
Distinguished University Professor and Professor of Law, Georgia State University College of Law and School of Public Health

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Leslie E. Wolf

Biosketch: Leslie Wolf is Distinguished University Professor and Professor of Law at Georgia State University College of Law and the School of Public Health. She served as interim dean of the College (2019-2021) and as director of the Center for Law, Health & Society (2014-2019).

Professor Wolf is a leading national scholar in health law, public health and ethics, with a focus on research ethics. She has conducted research on confidentiality risks and protections with a particular focus on Certificates of Confidentiality, research involving biospecimens, conflicts of interest, and IRB guidance, which has been funded by the National Institutes of Health and the Greenwall Foundation.

From 2016-2021, Professor Wolf was a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP). She continues to serve on SACHRP’s Subcommittee on Harmonization. She previously served on the Centers for Disease Control and Prevention’s Ethics Subcommittee to the Advisory Committee to the Director.

Jonathan Herington, PhD
Assistant Professor of Philosophy, University of Rochester

Many kinds of research can impose risks upon third parties, including research traditionally outside the scope of IRB review. Moreover, human subjects research regulations rely on principles of interpersonal ethics (respect for participant autonomy, favorable risk-benefit ratio) that may be difficult to satisfy in the context of widely-distributed social risks about which affected parties may reasonably disagree. Are third-party risks better conceptualized using frameworks from political philosophy? What can theorizing about justice tell us about the challenges and opportunities with respect to regulating third-party risk?

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Jonathan Herington

Biosketch: Jonathan Herington is an Assistant Professor of Philosophy at the University of Rochester. His research focuses on the political philosophy of science, health and technology. He applies the tools of political philosophy to issues arising in research ethics, the ethics of machine-learning algorithms, public health ethics, and environmental governance. Previously he was an Assistant Professor in the Department of Philosophy at Kansas State University and a Research Fellow in the Medicine, Ethics, Society and History unit of the University of Birmingham. He completed his PhD in the School of Philosophy, at the Australian National University.

James Lavery, PhD
Conrad N. Hilton Chair in Global Health Ethics, Professor, Hubert Department of Global Health, Rollins School of Public Health, Faculty for the Center for Ethics, Emory University

The paradigm for the regulation of research with human subjects embodied in the Common Rule is notable for its exclusive focus on risks to research participants. The decision to view other ethical implications of research, beyond those affecting individual research participants, as "out of scope" of the Common Rule policy, reflects administrative and regulatory management concerns more than ethical concerns. In this presentation I will argue that stakeholder theory offers a way to imagine a broader view of research ethics that is consistent with the core purpose of the Common Rule as a policy of Institutional accountability. I will discuss the implications for IRBs with some case examples of research in which the main ethical concerns lie beyond the protection of individual research participants.

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James Lavery

Biosketch: Jim Lavery is the inaugural Conrad N. Hilton Chair in Global Health Ethics, Professor in the Hubert Department of Global Health in the Rollins School of Public Health, and Faculty of the Center for Ethics, Emory University, Atlanta, Georgia. Prior to Emory he held positions at the National Institutes of Health, and at St. Michael’s Hospital and the University of Toronto. He is a Fellow of the Hastings Center and the 2017 recipient of the Global Forum for Bioethics in Research Award for Contributions to Progress in International Research. He is a member of the Board of Directors of the Council for Health Research for Development (COHRED) USA, Chair of the Scientific and Technical Advisory Committee of the Health Campaign Effectiveness Coalition at the Task Force for Global Health in Atlanta, and a member of the Bioethics Advisory Panel of Pfizer, Inc.

Jonathan Kimmelman, PhD
James McGill Professor of Medical Ethics, McGill University

Many would agree that IRBs do not function only to ensure  regulatory compliance, but also serve to safeguard the ethics of research and protection of humans in research. If the conduct of research puts third parties directly at risk, IRBs – as a recognized gatekeeper for protecting humans in research – seem to have a role to play.

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Jonathan Kimmelman

Biosketch: Jonathan Kimmelman, PhD, is James McGill Professor of Biomedical Ethics at McGill University, and directs the Biomedical Ethics Unit as well as his own research group, STREAM (Studies in Translation, Ethics and Medicine). Kimmelman’s research centers on ethical policy and scientific dimensions of clinical development. Kimmelman received the Maud Menten New Investigator Prize (2006), a CIHR New Investigator Award (2008), a Humboldt Bessel Award (2014), and was elected a Hastings Center Fellow (2018). He has sat on various advisory bodies within the U.S. NHLBI and NIAID, served for four tours of duty on U.S. National Academies of Medicine committees, and chaired the International Society of Stem Cell Research Guidelines for Stem Cell Research and Clinical Translation revision task force 2015-16. His research has been covered in major media outlets, including NPR’s All Things Considered, STATNews, and Nature. Kimmelman is deputy editor at Clinical Trials, and associate editor at Cell Med.

David B. Resnik JD, PhD
Bioethicist and Senior Ethics Specialist, Adjunct Professor of Philosophy and Religion, North Carolina State University, National Institute of Environmental Health Sciences, National Institutes of Health

The federal research regulations provide no guidance for IRB review of risks to third parties (other than fetuses) who are directly impacted by human subjects research, but  IRBs have ethical and legal obligations to address these risks. In this presentation, I will propose a framework for reviewing risks to identifiable third parties that involves four steps: 1) identifying risks; 2) assessing risks; 3) managing risks; and 4) communicating risks. I will also apply the framework to several real-world examples of epidemiological and clinical studies involving risks to third parties.

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David B. Resnik

Biosketch: David B. Resnik is a Bioethicist at the National Institute of Environmental Health Sciences, National Institutes of Health. Dr. Resnik has an M.A. and Ph.D. in philosophy from the University of North Carolina at Chapel Hill, a J.D. from Concord University School of Law, and a B.A. in philosophy from Davidson College. Dr. Resnik was an Associate and Full Professor of Medical Humanities at the Brody School of Medicine at East Carolina University (ECU) from 1998 to 2004, and an Associate Director of the Bioethics Center at ECU and University Health Systems from 1998 to 2004. Dr. Resnik was Assistant and Associate Professor of Philosophy at the University of Wyoming (UW) from 1990 to 1998, and Director of the Center for the Advancement of Ethics at UW from 1995 to 1998. Dr. Resnik has published over 300 articles and 10 books on various topics in philosophy and bioethics and is a Fellow of the American Association for the Advancement of Science. He serves on several editorial boards and is an Associate Editor of the journal Accountability in Research.

Daniel M. Hausman PhD
Research Professor, Center for Population-Level Bioethics, Rutgers University

These are grounds for enabling IRBs to take into account risks to third parties of the research process that are similar to those imposed on research subjects, especially since third parties are generally unable to consent to the research. IRBs should however continue to be prohibited from considering "possible long-range effects of applying knowledge gained in the research". IRBs are not well placed either to make moral appraisals of the results of research and their consequences or to determine whether research is a prudent use of limited resources.

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Daniel M. Hausman

Biosketch: Educated at Harvard, Cambridge, and Columbia Universities, Daniel Hausman taught at the University of Maryland, Carnegie Mellon, and for 32 years at the University of Wisconsin-Madison before accepting his current position at the Center for Population-Level Bioethics at Rutgers University. His research addresses methodological, metaphysical, and ethical issues at the boundaries between economics and philosophy, and is currently focused on the ethical appraisal of the use of cost-effectiveness information to allocate health care. The author of nearly 200 books and articles, Hausman also co-founded the journal, Economics and Philosophy with Michael McPherson. His most important books are The Inexact and Separate Science of Economics (1992), Causal Asymmetries (1998), Preference, Value, Choice, and Welfare (2012), Valuing Health: Well-being, Freedom, and Suffering (2015), and, with Michael McPherson and Debra Satz, Economic Analysis, Moral Philosophy and Public Policy. In 2009 Hausman was elected to the American Academy of Arts and Sciences.

These are many types of research that can pose risk to third parties, including non-human subjects research that typically does not fall under the oversight of IRBs. If the research community has a responsibility towards protecting third parties in research, who should be involved? Would IRBs have a part to play in this effort and if so, how? Should IRBs review and consider protections for third parties? What might be their limitations and how should these be dealt with?

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